CODS _Sink Unit Scrub.pdf

Attachment 1

Critical Operational Device Specification (CODS)

Title: Sink Unit Scrub

Requiring Activity / Agency Name: Army Contracting Command (ACC) / NATICK

Program Name: Program Executive Office Soldier (PEO Soldier), Soldier Medical Device (SMD)

Critical Specifications: The below are critical specifications and the minimum must be met in order for the device to be considered acceptable by the government. They are separated by “minimum” and “desired” columns.

The Government requires a total of 3 sink unit scrubs to carry out environmental, and operational testing in accordance with the Military Standard (MIL STD) 810H. The Government intends to purchase up to three (3) sink unit scrubs. The proposed sink unit scrub from the vendor shall be the same model/type per quote. Multiple model/type sink unit scrub shall not be considered within a single quote.

Instructions: Indicate “yes” or “no” under both minimum and desired columns below.

Additional comments may be added.

1. Critical Operational Device Specifications

Number

Operational

Characteristic Minimum Required Desired Characteristics

Food and Drug Administration (FDA) Regulatory Oversight

The Sink Unit Scrub shall be cleared by the FDA with a 510(k) approval if it is a Class II medical device.

If the system is a Class I medical device, it shall be registered with the FDA for human use.

Minimum Requirement

2 Water Supply

The system shall supply both hot and cold water. Minimum Requirement

Self-Contained

The system shall be self-contained with a tankless electric water heater pump

4 Temperature

The system shall provide adjustable water temperature from 100° Fahrenheit (F) to 145°F.

Minimum Requirement

5 Accessories The system shall include the following unattached accessories:

Desired additional accessories:

• External Water supply

• Electrical Supply

• Mixing faucet with gooseneck for hot and cold water

• Hot and cold faucet handles

• Waste hose assembly

• Water supply hose

• Filter assembly

• Electric Inlet Cord

• Surgical Soap Dispenser

Hands-free Operation

The system shall have hands-free water control capabilities.

7 Weight

The system shall weigh no more than 550 lbs.

Desired weight of no more than 300lbs.

8 Pressure

The system shall automatically repressurize the sink when the tank pressure is reduced to a preset lower limit, approximately 30 psi minimum.

9 Power

The power supply shall provide a balanced power source for the device, supporting both 110-120 VAC, 60Hz, and 220- 240 VAC, 50Hz. It must include auto-detection and simultaneous switching capability between both voltage ranges. Additionally, if battery charging is

10 Water Weight Accommodation

The system shall accommodate water weight of 100lbs.

Desired to accommodate water weight of 182 lbs.

Sink Bowl Volume Capacity

The sink bowl shall have a capacity of 35l”x12w”x14h” (5880 cubic inches.)

2. Critical Logistic Specifications

Operational

Characteristic Minimum Required Desired Characteristics

1 Repair Parts Support

Contractor shall provide a full listing of repair parts and distinguish the items to be considered high-failure repair parts (identified by OEM and Government Subject Matter Experts). The country of origin, availability, proprietary parts, and procurement accessibility of each item shall be provided on the list.

2 Warranty

The contractor shall provide a warranty for at least (1) year.

This warranty shall include all parts, In-House labor, and

Desired the contractor provides a warranty for at least 3 years.

technical support during the warranty period

This warranty shall include all parts, In-house labor, and technical support during the warranty period.

3 Manuals

The vendor shall provide 1 physical and 1 digital User and Operator Service Manuals with each system

Minimum Requirement

4 Trade Agreements Act (TAA) Compliance

The system shall be compliant with TAA regulations.

3. ADDITIONAL PERFORMANCE PARAMETERS

These are desired Additional Performance Parameters (APPs) but are not essential.

Additional Performance

Parameters (APPs) Requirement

The system should offer multiple mechanisms to trigger soap and water dispensing

Multiple mechanisms should trigger hands-free hot and cold water and soap dispensing.

The system should be readily collapsible, and reassembly should require no tools

The sink should be able to collapse to less than one half of its cubic size for transport and be reassembled in less than five (5) minutes without external tools.

3 Manufacturer Training

The manufacturer should train both the program management team and selected Service Members (Schoolhouse trainers) on the operation and maintenance of the system.

4 Harden Reusable Transport Case

A.) The system and all accessories should be contained in harden reusable transport cases (e.g. Hardigg, Pelican, ECS Case or Equivalent).

B.) The system should be designed to withstand MILSTD testing in accordance with (IAW) the following paragraphs:

501.7 High Temperature

502.7 Low Temperature 507.6 Humidity

511.7 Explosive Atmosphere

514.8 Vibration

516.8 Shock

517.3 Pyroshock

528.1 Mechanical Vibrations of Shipboard Equipment

(Type I- Environmental and Type II- Internally Excited)

5 Training Events The vendor provides service and installation training at 3 training events for 5 people

6 Surgical Tray The sink bowl can accommodate a 18”x24” try for surgical instrument washing and/or soaking.

(End of CODS)